The lack of a standardized source of human milk, available for research purposes, has seriously hampered scientific investigation of human milk as well as the majority of the nearly 4,000 unique, species-specific milks. Accordingly, it would be desirable to provide a standardized source of human milk that can be modified to reflect the various stages of lactation and various immune responses.
Although the presence of immunoglobulins in human milk has been acknowledged for a number of years, the specific role and function of each of the human milk immunoglobulins and their subclasses has been poorly understood. For the patient of any age suffering from an immune disorder, the worldwide gamma globulin shortage is impacting care to such a degree that some patients are unable to obtain treatment. Purified immunoglobulins from human milk hold the potential for a solution for this worldwide shortage. Accordingly, it would be desirable to provide formulations comprising higher levels of immunoglobulins isolated from human milk, as well as methods to deliver these formulations to patients.
It has been known for a long time by physicians, scientists and nutritionists that the best food or nutrition supplied to an infant is its own mother's milk, i.e., fresh human milk. Recent research has indicated that “species-specific” milk plays a significant role in disease prevention and the severity of disease when the infant does become ill. Until recently, the reasons behind the superiority of species-specific milk were not well understood, nor were the various components and the roles they play in development and disease prevention. It is recognized, however, that many situations arise wherein the infant cannot obtain its mother's milk and as a result a suitable replacement is desired. Artificial baby milks, predominantly based on cow's milk, have been prepared and used to nourish an infant but there is increasing evidence that infants fed artificial baby milks suffer long-term ill consequences. It has been suggested that the exposure of an infant to any foreign proteins, such as the bovine protein, during the first few days of life will increase the infant's chance of becoming afflicted with juvenile diabetes. Other ill effects include allergies, lowered immunity, gastrointestinal disorders, respiratory disease and other associated etiology. Although much effort has been made to improve synthetic infant milk formulas, attempting to make them more closely simulate mother's milk, the presence of living organisms and other “species-specific” cells that act in a way to trigger other disease preventing mechanisms in the infant, these efforts have proven futile.
According to Jenness and Sloan, human milk contains three major groups of constituents that carry strong “species-specific” and “organ-specific” missions: (1) constituents specific to both organ and species, including proteins and lipids; (2) constituents specific to organ but not species, including lactose; and (3) constituents specific to species but not to organ, including albumin and some immunoglobulins.
Human milk is not a uniform body fluid; instead, it is a secretion from the mammary gland of constantly changing composition. In nature, the composition of human milk changes not only from day to day, but also throughout the course of a single day. While the reasons and outcome of these changes are not fully understood, it is intuitive to believe that these changes benefit the species and that substantial advantages may be gained for the infant who is provided an opportunity to reap the benefits of a modified formulation of 100% human milk. Accordingly, it would be desirable to provide formulations comprising human milk proteins as nutritional supplements and therapeutics for patients in need of gamma globulin therapy.